Constriction device including tear resistant structures

ABSTRACT

A constriction device that constricts body tissue and is formed of relatively thin elastic material includes a tear resistance structure to preclude an inadvertent tear in the device from propagating through the device. The tear resistance structure includes a plurality of intersecting ribs formed in the elastic material. The ribs circumscribe the device and define rectangular, square, diamond, wavy, or knurled patterns.

RELATED APPLICATIONS

[0001] The present application is a continuation of U.S. applicationSer. No. 10/394,299, filed on Mar. 21, 2003, which is a continuation ofU.S. application Ser. No. 10/041,907, filed on Oct. 18, 2001, now U.S.Pat. No. 6,589,161, and claims priority benefit under 35 U.S.C. § 120.The present application also incorporates the foregoing disclosures byreference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention is generally directed to a constrictiondevice that constricts body tissue. The present invention is moreparticularly directed to a constriction device that includes tearresistant structures to preclude propagation of a tear in the device forprotecting the integrity of the constriction device.

[0004] 2. Description of the Related Art

[0005] Constriction devices have been contemplated for constricting bodytissue. Such devices have been considered for use, for example, intissue resection procedures and in treating pulmonary disease.

[0006] Chronic Obstructive Pulmonary Disease (COPD) has become a majorcause of morbidity and mortality in the United States over the lastthree decades. COPD is characterized by the presence of airflowobstruction due to chronic bronchitis or emphysema. The airflowobstruction in COPD is due largely to structure abnormalities in thesmaller airways. Important causes are inflammation, fibrosis, gobletcell metaplasia, and smooth muscle hypertrophy in terminal bronchioles.

[0007] The incidence, prevalence, and health-related costs of COPD areon the rise. In 1991, COPD was the fourth leading cause of death in theUnited States and had increased 33% since 1979.

[0008] COPD affects the patient's whole life. It has three mainsymptoms: cough; breathlessness; and wheeze. At first, breathlessnessmay be noticed when running for a bus, digging in the garden, or walkingup hill. Later, it may be noticed when simply walking in the kitchen.Over time, it may occur with less and less effort until it is presentall of the time.

[0009] COPD is a progressive disease and currently has no cure. Currenttreatments for COPD include the prevention of further respiratorydamage, pharmacotherapy, and surgery. Each is discussed below.

[0010] The prevention of further respiratory damage entails the adoptionof a healthy lifestyle. Smoking cessation is believed to be the singlemost important therapeutic intervention. However, regular exercise andweight control are also important. Patients whose symptoms restricttheir daily activities or who otherwise have an impaired quality of lifemay require a pulmonary rehabilitation program including ventilatorymuscle training and breathing retraining. Long-term oxygen therapy mayalso become necessary.

[0011] Pharmacotherapy may include bronchodilator therapy to open up theairways as much as possible or inhaled β-agonists. For those patientswho respond poorly to the foregoing or who have persistent symptoms,Ipratropium bromide may be indicated. Further, courses of steroids, suchas corticosteroids, may be required. Lastly, antibiotics may be requiredto prevent infections and influenza and pheumococcal vaccines may beroutinely administered. Unfortunately, there is no evidence that early,regular use of pharmacotherapy will alter the progression of COPD.

[0012] Lung transplantation is also an option. Today, COPD is the mostcommon diagnosis for which lung transplantation is considered.Unfortunately, this consideration is given for only those with advancedCOPD. Given the limited availability of donor organs, lung transplant isfar from being available to all patients.

[0013] About 40 years ago, it was first postulated that the tetheringforce that tends to keep the intrathoracic airways open was lost inemphysema and that by surgically removing the most affected parts' ofthe lungs, the force could be partially restored. Although the surgerywas deemed promising, the procedure was abandoned.

[0014] The lung volume reduction surgery (LVRS) was later revived. Inthe early 1990's, hundreds of patients underwent the procedure. However,the procedure has fallen out of favor due to the act that Medicarestopped remitting for LVRS. Unfortunately, data is relatively scarce andmany factors conspire to make what data exists difficult to interpret.The procedure is currently under review in a controlled clinical trial.However, what data does exist tends to indicate that patients benefitedfrom the procedure in terms of an increase in forced expiratory volume,a decrease in total lung capacity, and a significant improvement in lungfunction, dyspnea, and quality of life.

[0015] Improvements in pulmonary function after LVRS have beenattributed to at least four possible mechanisms. These include enhancedelastic recoil, correction of ventilation/perfusion mismatch, improvedefficiency of respiratory musculature, and improved right ventricularfilling.

[0016] The improvements in pulmonary function resulting from LVRS cannotbe ignored. However, the surgery is very invasive and fraught withcomplications. Among the complications is the potential for lung airleaks. Lung tissue is very thin and fragile, hence difficult to suturetogether. After a lung portion is sectioned and removed, the remaininglung is most often restructured with suture staples. In about thirtypercent (30%) of the cases, the difficulty with suturing lung tissueresults in air leaks. Treatment for such air leaks depends upon theirseverity and often, in the most serious cases, requires further openchest surgery.

[0017] Air leaks in lungs can be caused by other causes. With increasingage, a patient may develop a weakened section of lung which may thenrupture due to an extreme pressure differential, such as may result fromsimply a hard sneeze. AIDS patients can sufferer from air leaks in theirlungs. Air leaks in lungs can further be caused by a puncture from abroken rib or a stab wound.

[0018] The invention disclosed and claimed in copending U.S. applicationSer. No. 09/534,244, incorporated herein by reference, provides animproved therapy for treating COPD and air leaks in lungs. The therapyincludes a constriction device which, when deployed on a lung,suppresses air leaks in the lung tissue without requiring any suturingof the effected lung tissue. Still further, by constricting a largeenough portion of a lung with the device, lung volume reduction with theconcomitant improved pulmonary function may be obtained without the needfor any suturing of lung tissue at all.

[0019] The lung constriction device includes a jacket or sheath offlexible material configured to cover at least a portion of a lung. Thejacket has a pair of opened ends to permit the lung portion to be drawninto the jacket. The jacket is dimensioned to constrict the lung portionafter the lung portion is drawn therein. The lung constriction device ispreferably formed of expandable, such as elastic, material for receivingthe lung tissue while the device is in an expanded or enlargedcondition, and then contractible about the lung portion upon release ofthe expanded condition for constricting the lung tissue.

[0020] An important aspect of the device and method disclosed in U.S.application Ser. No. 09/534,244 is the ability to sever the constrictingdevice intermediate its ends. This allows a significant portion of theconstricted lung tissue to be removed altogether while permitting aportion of the constricting device to remain in the body for continuedsuppression of air leaks and maintenance of the remaining lung tissueintegrity.

[0021] Devices and methods similar to those disclosed in U.S.application Ser. No. 09/534,244 may be employed to advantage in otherand different procedures such as in general resection procedures and forbody tissue other than lung tissue. Resection procedures are commonlyperformed for such body tissue as, for example, atrial appendage tissue,ovarian tissue, gall bladder tissue, pancreatic tissue, appendix tissueand spleen tissue. Resection procedures may be required to treat cancer,organ damage, or organ disease, for example.

[0022] U.S. application Ser. No. 09/534,244 also discloses and claimsvarious methods and apparatus for deploying the constricting device onbody tissue such as lung tissue. One apparatus and method contemplatesmechanically expanding the device in a transverse dimension whilephysically pulling the tissue to be constricted into the device.

[0023] Another method contemplates mounting the device over a vacuumchamber and pulling the tissue into the vacuum chamber by engaging thetissue with an opened end of the chamber and then drawing a vacuum inthe chamber. This draws the tissue into the chamber. Then, the chamberis withdrawn from the device, leaving the tissue constricted in thedevice.

[0024] A further method contemplates inserting the device into a vacuumchamber and sealing the opened end of the chamber to the device. Theopened end of the chamber and the tissue are then brought into sealingengagement. A vacuum is next pulled in the chamber and the device topull the tissue into the device and chamber. Once the tissue is withinthe device, the chamber is removed from over the device leaving thetissue constricted in the device.

[0025] Although various methods and apparatus have been conceived foreffectively deploying constriction devices on body tissue, theconstriction devices, over time, may become dislodged due to the natureof the soft tissue on which they are deployed. More specifically, softbody tissue has a tendency to expand at the proximal end of the devicecausing longitudinal slippage of the device on the body tissue. This mayeventually lead to the device slipping totally free from the tissue.

[0026] To meet the needs for fixation, U.S. application Ser. No.09/902,821, filed Jul. 10, 2001, and incorporated herein by reference,discloses and claims a constriction device having positive fixationstructure for maintaining the constriction device deployed on the bodytissue.

[0027] One disclosed device includes a plurality of fixation elements onthe inner surface of the sleeve that grasp the body tissue upon releaseof the sleeve from the expanded condition. More particularly, thefixation elements are adjacent to one of the opposed openings andarranged in a side-by-side relation to grasp the body tissue betweenadjacent fixation elements when the sleeve is released from the expandedcondition. The fixation elements may be integral to the longitudinalside wall or adhered to the inner surface of the sleeve. Still further,the inner surfaces of the fixation elements may have roughened surfacesto further assist in grasping the constricted body tissue.

[0028] While the fixation structures disclosed and claimed in theaforementioned U.S. application Ser. No. 09/902,821 are believed to besufficient alone for maintaining the constriction device on theconstricted body tissue, other forms of fixation may be further employedalone or in combination with the above described fixation structures formaintaining the constriction device on the constricted body tissue. Oneadditional form of fixation widely practiced in the medical field issuturing.

[0029] While suturing would appear to be an option, simply suturing theconstriction device to the constricted body tissue would pose a numberof problems. Such problems would arise because the material from whichthe constriction device is formed is relatively thin elastic material.The suturing of such material could easily cause tearing of the deviceby the suture. Moreover, the very act of puncturing the device materialwith a suture needle could readily cause tearing of the device material.Copending U.S. application Ser. No. 09/969,949 filed Oct. 2, 2001 andincorporated herein by reference discloses a constriction deviceconfigured to permit the suturing of the device to constricted bodytissue while protecting against tearing of the device material by eitherthe suture or a suture needle.

[0030] In one disclosed embodiment, the device has an increasedthickness about each suture hole to reinforce the suture holes. Theincreased thickness may have a tapered cross section for guiding asuture needle into the suture holes and may extend from the innersurface of the device or from the outer surface of the device.

[0031] While the suture hole reinforcement mentioned above represents animportant advancement towards protecting the constriction device againsttears during suturing, there is still the possibility that the devicemay be accidentally punctured or torn outside of a suture hole duringdeployment. Since, as previously mentioned, the device takes the form ofa sleeve formed of relatively thin elastic material, still further tearresistance would be helpful for protecting against tear propagation. Thepresent invention provides such additional tear propagation protection.

SUMMARY OF THE INVENTION

[0032] The present invention provides a constriction device that is tearresistant. The device includes an elongated sleeve having at least oneopened end and being formed from elastic material to receive, when in anexpanded condition, body tissue to be constricted and to constrict thebody tissue when released from the expanded condition. The devicefurther includes a tear resistance structure about the sleeve thatprecludes propagation of a tear in the sleeve.

[0033] The tear resistance structure may be an increased thickness ofthe sleeve defining a plurality of ribs in the sleeve. The plurality ofribs may include a first plurality of ribs and a second plurality ofribs which intersect each other. The intersecting ribs may define apattern of squares, a pattern of diamonds, a pattern including waves, ora knurled pattern. Preferably the ribs are formed on an inner surface ofthe sleeve.

[0034] The present invention further provides a constriction device thatconstricts body tissue, the device including sleeve means formed ofelastic material including at least one opened end for constricting bodytissue received therein and tear resistance means about the sleeve forprecluding propagation of a tear in the sleeve means.

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Theinvention, together with further objects and advantages thereof, maybest be understood by making reference to the following descriptiontaken in conjunction with the accompanying drawings, in the severalfigures of which like reference numerals identify identical elements,and wherein:

[0036]FIG. 1 is a simplified sectional view of a thorax illustrating arespiratory system having a constricting device embodying the presentinvention deployed on a portion of a lung to effect lung volumereduction;

[0037]FIG. 2 is a sectional view similar to FIG. 1 but illustrating therespiratory system after the constricted lung portion has beenresectioned;

[0038]FIG. 3 is a perspective view illustrating a constricting deviceembodying the present invention;

[0039]FIG. 4 is a perspective view of the interior of the device of FIG.3 illustrating a tear resistance structure embodying the presentinvention;

[0040]FIG. 5 is a plan view of one tear resistance structure patternembodying the present invention;

[0041]FIG. 6 is a plan view of another tear resistance structure patternconfigured in accordance with another embodiment of the presentinvention;

[0042]FIG. 7 is a further plan view of still another tear resistancestructure pattern embodying the present invention; and

[0043]FIG. 8 is a still further plan view of another tear resistancestructure pattern embodying the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0044] Referring now to FIG. 1, it is a sectional view of a respiratorysystem 20. The respiratory system 20 resides within the thorax 22 whichoccupies a space defined by the chest wall 24 and the diaphragm 26.

[0045] The respiratory system 20 includes the trachea 28, the leftmainstem bronchus 30, the right mainstem bronchus 32, and the bronchialbranches 34, 36, 38, 40, and 42. The respiratory system 20 furtherincludes left lung lobes 52 and 54 and right lung lobes 56, 58, and 60.Each bronchial branch communicates with a respective different portionof a lung lobe, either the entire lung lobe or a portion thereof.

[0046] A healthy respiratory system has an arched or inwardly arcuatediaphragm 26. As the individual inhales, the diaphragm 26 straightens toincrease the volume of the thorax 22. This causes a negative pressurewithin the thorax. The negative pressure within the thorax in turncauses the lung lobes to fill with air to an inflated condition. Whenthe individual exhales, the diaphragm returns to its original archedcondition to decrease the volume of the thorax. The decreased volume ofthe thorax causes a positive pressure within the thorax which in turncauses exhalation of the lung lobes.

[0047]FIG. 1 also shows a constriction device 70 embodying the presentinvention deployed on lobe 58. The device 70 is configured as a sleeveor sheath formed of a sheet of elastic biocompatible material. Thematerial may be formed from silicone rubber, polyurethane, expandedpolytetraflouroethylene, polyester and polyurethane, or nylon andpolyurethane, for example. The sleeve is preferably opened at both endsand may be generally cylindrical in configuration.

[0048] The sleeve may be applied to the lung lobe while in an expandedcondition. This may be accomplished by expanding the sleeve with avacuum and then pulling the lung portion into the sleeve with thevacuum. When the lung portion is within the sleeve, the expansion of thedevice is released. With the expansion released, the sleeve is permittedto contract or collapse about the lung portion to constrict the lungportion.

[0049] The device 70 may be employed, for example, to suppress airleakages in lungs. It may also find use to advantage in constricting alung portion suffering from COPD to simulate or achieve lung volumereduction. All of the beneficial effects of lung volume reductionsurgery may be realized and, most importantly, without requiringsuturing of lung tissue. The constriction device 70 is sutured to theconstricted lung tissue by a suture 71. To that end, the device 70preferably includes a plurality of suture holes reinforced in accordancewith one of the embodiments described in the aforementioned pending U.S.application Ser. No. 09/969,949 so that neither the suture needle northe suture tears or adversely affects the integrity of the device 70.

[0050]FIG. 2 shows the respiratory system 20 after the constricted lungportion has been resectioned. The device 70 is preferably formed ofseverable material, such as, any of the materials previously described.This enables the device 70 to be severed or cut intermediate its endswith a suitable bladed instrument to resection the lung lobe 58. Theportion of the device 70 remaining on the lobe 58 continues to constrictthe lung tissue therein to form an effective seal from leakage. Thesuture 71 continues to maintain the device 70 on the remainingconstricted tissue. Hence, lung volume reduction is rendered anavailable treatment while negating the need of conventional lungsectioning and avoiding the potentially severe complications whichaccompany such a procedure.

[0051]FIGS. 3 and 4 illustrate a constriction device 110 embodying thepresent invention. As generally illustrated in FIG. 3, the device 110 isa generally cylindrical sleeve 111 having a longitudinal dimension 112and a transverse dimension 114. As previously mentioned, the device 110is preferably formed of a relatively thin elastic material permittingthe device to expand in the longitudinal dimension and more importantlyin the transverse dimension. For example, the device 110 may be formedfrom silicone. The device 110 has opposed opened ends 116 and 118. Thedevice may further include at one end, for example, end 118, an integralrim 120.

[0052] The device 110 further includes a plurality of suture holes 122.The suture holes 122 are preferably distributed about the device closelyadjacent the opened end 118. About each suture hole 122 is a suture holereinforcement structure 124. The suture hole reinforcement structure 124of each suture hole 122 is an increased thickness or thickened portionin the sleeve wall forming a ring shaped structure about each suturehole on the inner surface 130 of the sleeve 111. The reinforcementstructure 124 of each suture hole 122 may further define a taperedsurface to help guide a suture needle through its corresponding suturehole.

[0053] As may be best seen in FIG. 4, the device 110 further includes aplurality of fixation elements 132. The fixation elements are arrangedin side-by-side relation and project inwardly from the inner surface 130of the sleeve 111. As described in the aforementioned U.S. applicationSer. No. 09/902,821, adjacent fixation elements 132 grasp the bodytissue upon deployment of the sleeve to further maintain the device 110on the constricted body tissue.

[0054] With continued reference to FIG. 4, and in accordance with thepresent invention, the device 110 includes a tear resistance structure134. The tear resistance structure 134, in accordance with thisembodiment, is an increased thickness in the sleeve 111 defining aplurality of ribs or ridges including a first plurality 136 of ribs andsecond plurality 138 of ribs. The ribs 136 and 138 are formed on theinner surface 130 of the sleeve 111. The ribs are further arranged sothat the first plurality 136 and second plurality 138 of ribs intersecteach other. Here, the ribs intersect to form a pattern of rectangles.The rib pattern circumscribes the sleeve 111. By virtue of the tearresistance structure of the rib pattern, any nick or tear will beprecluded from propagating beyond the ribs or ridges enclosing the nickor tear. As a result, the overall integrity of the device 110 isprotected notwithstanding an accidental or inadvertent nick or tear inthe elastic material of the sleeve 111.

[0055]FIG. 5 shows another pattern in which the tear resistance ribs maybe formed. Here, first and second pluralities 150 and 152 of ribsintersect to form a diamond pattern. Other patterns are shown in FIGS.6-8. In FIG. 6, first and second pluralities 154 and 156 of ribsintersect to form a pattern of squares. In FIG. 7, the ribs form aknurled pattern 158. In FIG. 8, a first plurality 160 of ribs form apattern of waves which intersect a second plurality 162 of substantiallyparallel ribs. As will be appreciated by those skilled in the art, otherrib patterns may be used without departing from the present invention.

[0056] [53] While the invention has been described by means of specificembodiments and applications thereof, it is understood that numerousmodifications and variations could be made thereto by those skilled inthe art without departing from the spirit and scope of the invention. Itis therefore to be understood that within the scope of the claims, theinvention may be practiced otherwise than as specifically describedherein.

What is claimed is:
 1. A constriction device that constricts bodytissue, the device comprising: an elongated sleeve including at leastone opened end and being formed from elastic material to receive, whenin an expanded condition, body tissue to be constricted and to constrictthe body tissue when released from the expanded condition; and a tearresistance structure about the sleeve that precludes propagation of atear in the sleeve.
 2. The device of claim 1 wherein the tear resistancestructure is an increased thickness of the sleeve.
 3. The device ofclaim 1 wherein the tear resistance structure is a plurality of ribs inthe sleeve.
 4. The device of claim 3 wherein the plurality of ribsinclude a first plurality of ribs and a second plurality of ribs andwherein the first and second pluralities of ribs intersect each other.5. The device of claim 4 wherein the first and second pluralities ofribs intersect each other to form a pattern of squares.
 6. The device ofclaim 4 wherein the first and second pluralities of ribs intersect eachother to form a pattern of diamonds.
 7. The device of claim 4 whereinone of the first and second pluralities of ribs forms a pattern ofwaves.
 8. The device of claim 7 wherein the pattern of waves iscircumferential about the sleeve.
 9. The device of claim 3 wherein theplurality of ribs forms a knurl pattern.
 10. The device of claim 1wherein the tear resistance structure is on an inner surface of thesleeve.
 11. A constriction device that constricts body tissue, thedevice comprising: sleeve means formed of elastic material including atleast one opened end of constricting body tissue received therein; andtear resistance means about the sleeve for precluding propagation of atear in the sleeve means.
 12. The device of claim 11 wherein the tearresistance means is an increased thickness of the sleeve.
 13. The deviceof claim 11 wherein the tear resistance means is a plurality of ribs inthe sleeve.
 14. The device of claim 13 wherein the plurality of ribsinclude a first plurality of ribs and a second plurality of ribs andwherein the first and second pluralities of ribs intersect each other.15. The device of claim 14 wherein the first and second pluralities ofribs intersect each other to form a pattern of squares.
 16. The deviceof claim 14 wherein the first and second pluralities of ribs intersecteach other to form a pattern of diamonds.
 17. The device of claim 14wherein one of the first and second pluralities of ribs forms a patternof waves.
 18. The device of claim 17 wherein the pattern of waves iscircumferential about the sleeve.
 19. The device of claim 13 wherein theplurality of ribs forms a knurl pattern.
 20. The device of claim 11wherein the tear resistance means is on an inner surface of the sleeve.